This invention will be discussed in particular in relation to the delivery and cannulation of thoracoabdominal stent grafts but the invention is not so limited.
Thoracoabdominal aneurysms are particularly difficult to treat due to the inclusion of four branch vessels (celiac artery, superior mesenteric artery, and renal arteries). Endovascular devices are available which include four branches, but cannulation of each branch independently can be difficult and time consuming, exposing the patient to large amount of contrast and x-rays.
Preloaded wires associated with a fenestrated stent graft and a delivery device have been demonstrated to greatly ease the process of cannulating the branches of the device. In the case of a thoracoabdominal aneurysm, a fenestrated or side arm stent graft with four preloaded wires with catheters or sheaths are required for the four side branches or fenestrations. Since a preloaded delivery system including four lumens for four catheters or preloaded sheaths in the delivery device would be unacceptably large (28 Fr), an alternative option is to individually cannulate the branches using preloaded guide wires from a brachial access site. To accomplish this, the preloaded wires must be inserted from the femoral access with a main delivery device and tracked through the abdominal and thoracic aorta, and out through the brachial artery.
PCT Patent Application Number PCT/US2011/029037 (published as WO 2011/116308) entitled “INTRODUCER WITH EXTENSION” lodged on 18 Mar. 2011 discloses devices and arrangements for delivery of fenestrated or branched stent grafts using delivery devices incorporating preloaded guide wires and the teaching therein is incorporated herein in its entirety.
The assembly of an endovascular delivery device incorporating indwelling guide wires requires that there be some way of ensuring that a manufacturer places the correct indwelling wire into the correct side arm and then that a physician using the device will know which indwelling guide wire passes through which side arm. During introduction and placement a delivery device is often rotated to encourage it to pass trough the vasculature and it may in fact remain partially twisted. Some method is needed to ensure that a physician knows the actual orientation of the endovascular device so that the physician knows which indwelling wire is which when most of the device is hidden within the human or animal body.
It is to overcome some of these problems that the present invention is directed or to alt least provide the practitioner with a useful alternative.
Throughout this specification the term distal with respect to a portion of the aorta, a deployment device or a prosthesis means the end of the aorta, deployment device or prosthesis further away in the direction of blood flow away from the heart and the term proximal means the portion of the aorta, deployment device or end of the prosthesis nearer to the heart. When applied to other vessels similar terms such as caudal and cranial should be understood.